The purpose of this study is to evaluate how well nipocalimab works as compared to placebo in participants with moderate to severe Systemic lupus erythematosus (SLE, a long-term disease where the immune system mistakenly attacks its own healthy tissues, causing swelling and redness in various organs).

A Study of Nipocalimab in Adults With Moderate to Severe Systemic Lupus Erythematosus

Lupus Erythematosus, Systemic

Systemic Lupus Erythematosus

Rheumatology

Immune system conditions

Placebo

Nipocalimab

Standard of care treatment

A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Nipocalimab in Adults With Moderate to Severe Systemic Lupus Erythematosus

SLE SRI-4 composite response is a composite response of at least a 4 point reduction in SLE Disease Activity Index 2000 (SLEDAI-2K), no British Isles Lupus Assessment Group-2004 (BILAG-2004) worsening, defined as no new A or less than or equal to <= 1 new B items compared to baseline, no worsening in Physician's Global Assessment (PGA [greater than {>} 10 percent {%} increase from baseline]).

SLE SRI-4 composite response is a composite response of at least a 4 point reduction in SLEDAI-2K, no BILAG-2004 worsening, defined as no new A or <= 1 new B items compared to baseline, no worsening in PGA (> 10% increase from baseline). IFN high is defined as elevated peripheral type 1 IFN gene signature at baseline.

SLE SRI-4 composite response is a composite response of at least a 4 point reduction in SLEDAI-2K, no BILAG-2004 worsening, defined as no new A or <= 1 new B items compared to baseline, no worsening in PGA (> 10% increase from baseline). Sustained reduction in oral GC dose at Week 52 is defined as achieving <= 5 mg/day oral prednisone (or equivalent) AND no increase of that dose from Week 32 through Week 52.

LLDAS is defined as follows: SLEDAI-2K <= 4, with no activity in major organ systems (renal, central nervous system, cardiopulmonary, vasculitis, fever) and no hemolytic anemia or gastrointestinal activity measured as maintaining a D (no disease activity but suggests the system had previously been affected) or E (no current or previous disease activity) score in BILAG gastrointestinal body system, no new lupus disease activity compared with the previous assessment measured as no new or worsening individual BILAG parameters, physician's global assessment of disease activity <= 1 on a 3-point visual analog scale from no disease activity to severe disease activity, a current prednisolone (or equivalent) dose <= 7.5 milligram (mg) daily and well-tolerated standard maintenance doses of immunosuppressive drugs and approved biological agents.

Percentage of participants with < 2 active joints at Week 52 in participants with >= 2 active joints at baseline will be reported.

Lupus symptoms joint pain score at Week 52 will be reported.

Percentage of participants achieving sustained reduction in oral GC dose at Week 52 in participants treated with oral GC >5 mg/Day prednisone (or equivalent) at baseline will be reported.

FACIT-Fatigue version 4.0 is a 13-item questionnaire that assesses participant-reported fatigue and its impact upon daily activities and function over the past 7 days. Participants will be asked to answer each question using a 5-point Likert scale (0=Not at all; 1=A little bit; 2=Somewhat; 3=Quite a bit; and 4=Very much). FACIT-Fatigue has a total score range from 0 to 52, with 0 being the worst possible score and 52 the best.

A participant has a flare-free status if no flare has been reported during the 52-week treatment period. A flare was defined as either 1 or more new BILAG-2004 A (severe disease activity) or 2 or more new BILAG-2004 B (moderate disease activity) items compared to the previous visit.

SLE SRI-4 composite response is a composite response of at least a 4 point reduction in SLEDAI-2K, no BILAG-2004 worsening, defined as no new A or <= 1 new B items compared to baseline, no worsening in PGA (> 10% increase from baseline). Autoantibody high participants is defined as participants with high autoantibody at baseline.

Participants will receive nipocalimab up to Week 52 in the double blind treatment period along with standard of care treatments. At Week 52, eligible participants from both studies will have the option to enter an open-label long-term extension (OLE) period, where they will continue to receive nipocalimab until Week 156 or until the study intervention is discontinued.

Participants will receive placebo up to Week 52 in the double blind treatment period along with standard of care treatment. At Week 52, eligible participants from both studies will have the option to enter an OLE period, where they will continue to receive nipocalimab until Week 156 or until the study intervention is discontinued.

The purpose of this study is to evaluate how well nipocalimab works as compared to
placebo in participants with moderate to severe Systemic lupus erythematosus (SLE, a
long-term disease where the immune system mistakenly attacks its own healthy tissues,
causing swelling and redness in various organs).

MUDr Angelika Lapcikova iMedica s r o

SLE SRI-4 composite response is a composite response of at least a 4 point reduction in
SLE Disease Activity Index 2000 (SLEDAI-2K), no British Isles Lupus Assessment Group-2004
(BILAG-2004) worsening, defined as no new A or less than or equal to <= 1 new B items
compared to baseline, no worsening in Physician's Global Assessment (PGA [greater than
{>} 10 percent {%} increase from baseline]).

SLE SRI-4 composite response is a composite response of at least a 4 point reduction in
SLEDAI-2K, no BILAG-2004 worsening, defined as no new A or <= 1 new B items compared to
baseline, no worsening in PGA (> 10% increase from baseline). IFN high is defined as
elevated peripheral type 1 IFN gene signature at baseline.

SLE SRI-4 composite response is a composite response of at least a 4 point reduction in
SLEDAI-2K, no BILAG-2004 worsening, defined as no new A or <= 1 new B items compared to
baseline, no worsening in PGA (> 10% increase from baseline). Sustained reduction in oral
GC dose at Week 52 is defined as achieving <= 5 mg/day oral prednisone (or equivalent)
AND no increase of that dose from Week 32 through Week 52.

LLDAS is defined as follows: SLEDAI-2K <= 4, with no activity in major organ systems
(renal, central nervous system, cardiopulmonary, vasculitis, fever) and no hemolytic
anemia or gastrointestinal activity measured as maintaining a D (no disease activity but
suggests the system had previously been affected) or E (no current or previous disease
activity) score in BILAG gastrointestinal body system, no new lupus disease activity
compared with the previous assessment measured as no new or worsening individual BILAG
parameters, physician's global assessment of disease activity <= 1 on a 3-point visual
analog scale from no disease activity to severe disease activity, a current prednisolone
(or equivalent) dose <= 7.5 milligram (mg) daily and well-tolerated standard maintenance
doses of immunosuppressive drugs and approved biological agents.

Percentage of participants with < 2 active joints at Week 52 in participants with >= 2
active joints at baseline will be reported.

Percentage of participants achieving sustained reduction in oral GC dose at Week 52 in
participants treated with oral GC >5 mg/Day prednisone (or equivalent) at baseline will
be reported.

FACIT-Fatigue version 4.0 is a 13-item questionnaire that assesses participant-reported
fatigue and its impact upon daily activities and function over the past 7 days.
Participants will be asked to answer each question using a 5-point Likert scale (0=Not at
all; 1=A little bit; 2=Somewhat; 3=Quite a bit; and 4=Very much). FACIT-Fatigue has a
total score range from 0 to 52, with 0 being the worst possible score and 52 the best.

A participant has a flare-free status if no flare has been reported during the 52-week
treatment period. A flare was defined as either 1 or more new BILAG-2004 A (severe
disease activity) or 2 or more new BILAG-2004 B (moderate disease activity) items
compared to the previous visit.

SLE SRI-4 composite response is a composite response of at least a 4 point reduction in
SLEDAI-2K, no BILAG-2004 worsening, defined as no new A or <= 1 new B items compared to
baseline, no worsening in PGA (> 10% increase from baseline). Autoantibody high
participants is defined as participants with high autoantibody at baseline.

Participants will receive nipocalimab up to Week 52 in the double blind treatment period
along with standard of care treatments. At Week 52, eligible participants from both
studies will have the option to enter an open-label long-term extension (OLE) period,
where they will continue to receive nipocalimab until Week 156 or until the study
intervention is discontinued.

Participants will receive placebo up to Week 52 in the double blind treatment period
along with standard of care treatment. At Week 52, eligible participants from both
studies will have the option to enter an OLE period, where they will continue to receive
nipocalimab until Week 156 or until the study intervention is discontinued.

Arthritis & Rheumatic Disease Specialties

Joint and Muscle Research Institute

Amarillo Center for Clinical Research

Meir Medical Center

Tel Aviv Sourasky Medical Center

Tokai University Hospital

Kaohsiung Veterans General Hospital

Kaohsiung Chang Gung Memorial Hospital

Advanced Medical Research

Texas Rheumatology Research Institute LLC

Instituto de Investigaciones Clinicas Quilmes

MR Medicina Reumatologica

Inland Rheumatology Clinical Trials Inc.

Rambam Health Care Campus

David S Hallegua MD A Professional Corporation

Avanti Clinical Research Corp

LeJenue Research Associates PLLC

A Study of Nipocalimab in Adults With Moderate to Severe Systemic Lupus Erythematosus

Trials at a glance

Trials at a glance

A Study of Nipocalimab in Adults With Moderate to Severe Systemic Lupus Erythematosus

Outcome measures

Primary outcome measures

Secondary outcome measures